System and method for defining stimulation programs including burst and tonic stimulation

ABSTRACT

In one embodiment, a method for defining a stimulation program for electrical stimulation of a patient, the method comprising: providing a single screen user interface that comprises a first plurality of controls and a second plurality of controls, the first plurality of controls allowing selection of multiple stimulation parameters for a plurality of stimulation sets, the second plurality of controls allowing selection of multiple stimulation parameters defining burst stimulation and tonic stimulation; receiving user input in one or more of the second plurality of controls; and automatically modifying parameters for one or more stimulation sets in response to receiving the user input in one or more of the second plurality of controls and modifying values displayed in one or more controls of the first plurality of controls according to the modified parameters, the modified parameters reflecting a stimulation program that includes an interleaved pattern of burst stimulation and tonic stimulation for delivery to the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/423,124, filed Apr. 14, 2009, now U.S. Pat. No. 8,340,775, whichclaims the benefit of U.S. Provisional Application No. 61/044,680, filedApr. 14, 2008, the disclosures of which are fully incorporated herein byreference for all purposes.

TECHNICAL FIELD

This application is generally related to systems and methods forcreating stimulation programs including burst stimulation and tonicstimulation to treat various neurological disorders or conditions.

BACKGROUND

Different firing modes or frequencies occur in the brain and/or otherneuronal tissue, for example tonic firing and burst firing (irregular orregular burst firing). Such firing modes can be utilized for normalprocessing of information, however, alteration of the firing modes, mayalso lead to pathology.

For example, certain neurological conditions are associated withhyperactivity of the brain and can be traced to a rhythmic burst firingor high frequency tonic firing (e.g., tinnitus, pain, and epilepsy).Other conditions can be associated with an arrhythmic burst firing or adesynchronized form of tonic and burst firing (e.g., movement disordersand hallucinations).

During the past decade, neuromodulation systems have been used tomodulate various areas of the brain, spinal cord, or peripheral nerves(see, for example, U.S. Pat. Nos. 6,671,555; 6,690,974). These types ofsystems utilize tonic forms of electrical stimulation. Recently bursttranscranial magnetic stimulation (TMS) at theta frequencies has beendeveloped. Theta burst TMS has been shown to produce an effect on motorand visual cortex by suppressing excitatory circuits after a shortapplication period of only 20-190 s.

SUMMARY

In one embodiment, a method for defining a stimulation program forelectrical stimulation of a patient, the method comprising: providing asingle screen user interface that comprises a first plurality ofcontrols and a second plurality of controls, the first plurality ofcontrols allowing selection of multiple stimulation parameters for aplurality of stimulation sets, the second plurality of controls allowingselection of multiple stimulation parameters defining burst stimulationand tonic stimulation; receiving user input in one or more of the secondplurality of controls; and automatically modifying parameters for one ormore stimulation sets in response to receiving the user input in one ormore of the second plurality of controls and modifying values displayedin one or more controls of the first plurality of controls according tothe modified parameters, the modified parameters reflecting astimulation program that includes an interleaved pattern of burststimulation and tonic stimulation for delivery to the patient.

The foregoing has outlined rather broadly certain features and/ortechnical advantages in order that the detailed description that followsmay be better understood. Additional features and/or advantages will bedescribed hereinafter which form the subject of the claims. It should beappreciated by those skilled in the art that the conception and specificembodiment disclosed may be readily utilized as a basis for modifying ordesigning other structures for carrying out the same purposes. It shouldalso be realized by those skilled in the art that such equivalentconstructions do not depart from the spirit and scope of the appendedclaims. The novel features, both as to organization and method ofoperation, together with further objects and advantages will be betterunderstood from the following description when considered in connectionwith the accompanying figures. It is to be expressly understood,however, that each of the figures is provided for the purpose ofillustration and description only and is not intended as a definition ofthe limits of the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B respectively depict conventional percutaneous and paddleleads that may be utilized to deliver burst and tonic stimulationpatterns according to some embodiments.

FIG. 2 depicts a stimulation system that can be used to deliver burstand tonic stimulation according to some embodiments.

FIG. 3 depicts a block diagram of an implantable pulse generator thatcan be programmed to generate burst and tonic stimulation according tosome embodiments.

FIG. 4 depicts a stimulation program in which various parameters can beselected to define pulses of a burst and tonic stimulation patternaccording to one representative embodiment.

FIG. 5 depicts a stimulation program for defining burst and tonicstimulation according to one representative embodiment.

FIG. 6 depicts a combination of burst stimulation and tonic stimulationthat can be used to treat a neurological condition or disorder accordingto one representative embodiment.

FIG. 7 depicts a user interface that can be employed to define burst andtonic stimulation according to one representative embodiment.

DETAILED DESCRIPTION

As used herein, the term “stimulate” or “stimulation” refers toelectrical, and/or magnetic, stimulation that modulates one or moreneuronal sites.

As used herein, the term “tonic stimulation” refers to a stimulationpattern in which individual pulses occur with relatively longinter-spike intervals or equivalently at relatively lower frequencies.The inter-spike intervals for tonic stimulation are sufficiently longthat significant temporal summation of cellular depolarizations does notoccur.

As used herein, “burst stimulation” refers to pulses generated by apulse generator that is similar to burst firing of action potentialswithin neural tissue. Specifically, burst stimulation includes multiplediscrete bursts with each burst comprising multiple pulses or spikes.Burst stimulation may occur from a plateau or elevated pulse amplitudeapplied by the pulse generator. Also, a hyper-polarizing or otherpre-conditioning pulse may precede the burst. A charge balancing pulseor pulses may be applied within the burst or at the end of the burst.Within an individual burst of electrical pulses, the pulses areseparated from each adjacent pulse by an inter-pulse interval. Theinter-pulse interval can be about 0.5 microseconds to about 10milliseconds. The intra-burst spike rate does not necessarily occur at afixed rate and can be variable within an individual burst. The period oftime between two bursts is referred to as the “inter-burst interval.”The inter-burst interval may not be affected by the presence of anynumber of tonic spikes located anywhere within a series of two or morebursts.

The combination of burst stimulation and tonic stimulation in astimulation pattern is believed to offer benefits for a number ofneurological conditions or disorders that were not previously achievableusing conventional stimulation techniques.

For example, tinnitus is an auditory phantom percept related toreorganization and hyperactivity of the auditory system. The auditorysystem consists of two main parallel pathways supplying auditoryinformation to the cerebral cortex: the topographically organizedlemniscal (classical) system, and the non-topographic extralemniscal(non-classical) system. The classical pathways use the ventral thalamus,the neurons of which project to the primary auditory cortex whereas thenon-classical pathways use the medial and dorsal thalamic nuclei thatproject to the secondary auditory cortex and association cortices, thusbypassing the primary cortex. While neurons in the classical pathwaysonly respond to one modality of sensory stimulation, many neurons in thenon-classical pathway respond to more than one modality. Neurons in theventral thalamus fire in a tonic or semi-tonic mode while neurons in themedial and dorsal thalamus fire in bursts. The non-classical pathwaysreceive their input from the classical pathways, which means that theascending auditory pathways are a complex system of at least two mainparallel systems that provide different kinds of processing and whichinteract with each other in a complex way. Both systems provide sensoryinput to the amygdala through a long cortical route, and in addition,the non-classical pathways provide subcortical connections to thelateral nucleus of the amygdala from dorsal thalamic nuclei.

Studies in humans have indicated that some patients with tinnitus havean abnormal activation of the non-classical auditory system. Studies ofanimal models of tinnitus have shown that burst firing is increased inthe non-classical system and tonic firing activity is increased in theclassical system. Interestingly, not only tonic firing but also burstfiring is increased in neurons in the primary auditory cortex in animalmodels of tinnitus. Studies in patients with intractable tinnitus haveshown that tonic electrical stimuli of the primary and secondaryauditory cortex can suppress pure tone tinnitus, but not whitenoise/narrow band noise tinnitus.

It has been hypothesized that noise-like tinnitus may be caused byincreased burst firing in the non-topographic (extralemniscal) system,whereas pure tone tinnitus may be the result of increased tonic firingin the topographic (lemniscal) system. Transcranial magnetic stimulation(TMS), a non-invasive tool, was shown to modulate the neuronal activityof the auditory cortex thereby modulating the perception of tinnitus. Ithas been demonstrated that tonic stimulation can suppress pure tonetinnitus, but not narrow band noise, whereas burst TMS can suppressnarrow band or white noise tinnitus (noise-like).

In the clinical setting, cases of tinnitus are commonly complex in thatthe patient suffers from more than one type (i.e. pure tone, narrowband, white noise) of tinnitus in one or both ears. It is believed thatonly one of tonic mode stimulation and burst mode stimulation is notcapable of alleviating the symptoms for such patients.

To determine the ability of the combination of burst and tonicstimulation to treat tinnitus symptoms, four patients with bothunilateral noise-like and pure tone (VR) tinnitus were implanted withelectrodes for stimulation therapy using both tonic and burststimulation parameters. In three patients, the stimulation leads(Lamitorode 44 stimulation lead available from ANS Medical, Plano, Tex.,USA) were implanted adjacent to the auditory cortex, and one patient wasimplanted with a cervical dorsal column stimulation lead (Lamitrode 44stimulation lead). All patients underwent burst stimulation at 6, 18, or40 Hz consisting of 5 spikes with 1 ms pulse width, 1 ms interspikeinterval in a charged balanced manner and 6, 18, or 40 Hz tonic modeinterspersed between or around the bursts. The stimuli were delivered byan 8 channel digital neurostimulator (DS8000, World PrecisionInstruments, Hertfordshire, England/Sarasota, Fla., USA), capable ofdelivering tonic and burst mode stimulation.

If the patients benefited from the stimulation, a commercially availableIPG capable of burst mode was implanted (EON® implantable pulsegenerator from ANS Medical, Plano, Tex., USA), programmed with similarsettings, using a programmer. The only difference to the stimulidelivered with the external stimulator and the EON® implantable pulsegenerator, was the ramping used with the EON® implantable pulsegenerator (FIG. 2). The ramping characteristics of the burst pulses werechosen to model naturally occurring burst firing as closely as possible.

The below Table 1 shows that by using a combination of tonic and burststimulation parameters patients suffering from pure tone and noise-liketinnitus can be treated. The tonic and burst stimulation can be combinedon the same poles or center tone or surrounding the burst stimulationwith tonic stimulation.

TABLE 1 Intra-Burst Spikes Suppression Patient Freq Burst Tonic SpikeRate # of Tinnitus PB (DC)  6 Hz Yes Yes 500 Hz 5 95% RM (AC) 40 Hz YesYes 500 Hz 5 100%  DA (AC) 40 Hz Yes Yes 500 Hz 5 90% VR (AC) 18 Hz YesYes 500 Hz 5 90%

Thus, in cases of complex tinnitus combinations of burst and tonic modestimulation were shown to effectively reduce the occurrence and severityof symptoms. Although tonic mode stimulation alone is sufficient toreduce symptom occurrence and severity in many simple cases of pure tonetinnitus, the symptoms are rarely completely abolished. Moreover, inmany cases where symptoms are reduced, the effect of tonic modestimulation is relatively short lasting and repeated treatments resultin significantly reduced efficacy over time. Stimulation protocolscombining burst and tonic mode stimulation are significantly moreeffective at reducing symptoms in patients suffering from pure tonetinnitus, the effects of a single treatment last longer, and there is nosignificant reduction in efficacy with repeated treatment. Yet further,the combination of burst and tonic stimulation is effective at reducingthe symptoms or severity of patients that suffer from both pure tonetinnitus and noise-like tinnitus. Yet further, the combination of burstand tonic stimulation can act as an anti-habituation protocol.

In view of the above results for the combination of burst and tonicstimulation, one of skill in the art can realize that such stimulationprotocols can be used to treat neurological diseases/disorders havingboth a topographic (lemniscal system) and the non-topographic system(extralemniscal system) component. One such exemplary disease/disordermay include chronic pain. For example, typically, tonic stimulation isused to treat chronic pain. Tonic stimulation alters the topographic orlemniscal system resulting in the treatment of chronic pain. Thedownside to using tonic stimulation to treat chronic pain is thattypically the pain may be replaced with paresthesias, which acts throughthe non-topographic system. Thus, an alternative to treat chronic painwithout paresthesias may be to utilize a stimulation protocol thatemploys both burst and tonic stimulation, thereby altering both thenon-topographic and the topographic system to result in treatment ofchronic pain.

Yet further, another advantage of this type of combination protocol isthe ability of this combination of stimulation to reduce and/or preventanti-habituation or anti-adaptation of electrical stimulation. Those ofskill in the art are aware of the problem that occurs with continualelectrical stimulation in that the brain may adapt to the stimulationand the protocol is no longer effective to treat the symptoms. Thus, acombination protocol as described herein can alleviate this type ofadaptation and or habituation.

Burst and tonic stimulation can be applied to neuronal tissue of apatient using any known or later developed stimulation lead such aspercutaneous leads and paddle leads. As shown in FIG. 1A, a percutaneouslead 100 typically has two or more equally-spaced electrodes 101 whichare placed above the dura layer through the use of a Touhy-like needle.For insertion, the Touhy-like needle is passed through the skin betweendesired vertebrae to open above the dura layer. A commercially availableexample of an eight-electrode percutaneous lead is the OCTRODE® leadmanufactured by Advanced Neuromodulation Systems, Inc. Electrodes 101emit electrical stimulation energy generally radially (i.e., generallyperpendicular to the axis of stimulation lead 100) in all directions. Incontrast to a percutaneous lead 100, a paddle lead 150 (FIG. 1B) has apaddle configuration and typically possess a plurality of electrodes(for example, two, four, eight, or sixteen) arranged in one or morecolumns. Electrodes of paddle lead 150 emit electrical stimulationenergy in a direction generally perpendicular to the surface ofstimulation lead 150 on which they are located. A commercially availableexample of a paddle lead 150 is the LAMITRODE 44® lead, which ismanufactured by Advanced Neuromodulation Systems, Inc.

Referring to FIG. 2, stimulation system 200 can be programmed togenerate and deliver burst and tonic stimulation according to onerepresentative embodiment. System 200 comprises implantable pulsegenerator (IPG) 210, stimulation lead 150, and controller 250. IPG 210can be coupled to any number or types of stimulation leads directlythrough the header of IPG 210 or indirectly through one or more“extensions,” which are known in the art. In an alternative embodiment,electrodes can be integrated with the housing of IPG 210 and IPG 210 canbe implanted directly at the site where stimulation is applied toneuronal tissue.

IPG 210 typically comprises a metallic housing that encloses the pulsegenerating circuitry, control circuitry, communication circuitry,battery, recharging circuitry, etc. of the device. An example of acommercially available IPG is the EON® IPG available from AdvancedNeuromodulation Systems, Inc. IPG 210 also typically comprises a headerstructure for electrically and mechanically coupling to one or morestimulation leads. The electrical pulses generated by IPG 210 areconducted through conductors (not shown) embedded within stimulationlead 150 and delivered to tissue of the patient using electrodes 101 ata distal end of stimulation lead 150.

IPG 210 is preferably adapted to communicate with external devices, suchas controller 250, after implantation within a patient. For example,controller 250 may utilize wireless link 270 to communicate with IPG 210after IPG 210 is implanted within a patient to control the operations ofIPG 210. Controller 250 can be implemented by utilizing a suitablehandheld processor-based system that possesses wireless communicationcapabilities. The wireless communication functionality can be integratedwithin the handheld device package or provided as a separate attachabledevice. The interface functionality of controller 250 is implementedusing suitable software code for interacting with the clinician andusing the wireless communication capabilities to conduct communicationswith IPG 210.

A doctor, another clinician, the patient, or another user may usecontroller 250 located external to the person's body to provide controlsignals for operation of IPG 210. In some representative embodiments,controller 250 preferably provides a user interface that is adapted toallow a clinician to efficiently define a stimulation program thatincludes burst stimulation and tonic stimulation. IPG 210 modifies itsinternal parameters in response to the control signals to vary thestimulation parameters of stimulation pulses transmitted throughstimulation lead 150 to the predetermined neuronal tissue.

IPG 210 can be controlled by the signals from controller 250 to allowthe various characteristics of the burst stimulus to be set by aclinician to allow the combination of the burst stimulus and tonicstimulus to be optimized to treat a patient's specific disorder orcondition. For example, the spike amplitude, the inter-spike interval,the inter-burst interval, the number of bursts to be repeated insuccession, the amplitude of the various pulses, the placement and/ortiming of the tonic stimulus in relation to the burst stimulus, theamplitude of the tonic stimulus, the frequency of the tonic stimulus,the ratio of the burst stimulus to the tonic stimulus, altering thecharge of the burst and/or tonic stimulus, altering the use of biopolarand/or unipolar or monopolar pulses (e.g., unipolar burst stimulus andbipolar tonic stimulus or bipolar burst stimulus and unipolar tonicstimulus) and other such characteristics could be controlled usingrespective parameters accessed by the microcontroller during burststimulus and/or tonic stimulus operations.

Conventional implantable pulse generators devices typically include amicrocontroller and a pulse generation module. The pulse generationmodule generates the electrical pulses according to a defined pulsewidth and pulse amplitude and applies the electrical pulses to definedelectrodes. The microcontroller controls the operations of the pulsegeneration module according to software instructions stored in thedevice and accompanying stimulation parameters. According to someembodiments, the control signals provided by controller 250 devices canbe selected to cause the microcontroller to deliver a number of spikes(relatively short pulse width pulses) that are separated by anappropriate inter-spike interval. Thereafter, the programming of themicrocontroller causes the pulse generation module to cease pulsegeneration operations. The controls signals provided to themicrocontroller also causes a repetition of the spike generation andcessation of operations for a predetermined number of times. After thepredetermined number of repetitions have been completed, themicrocontroller can cause burst stimulation to cease for an amount oftime, deliver a tonic pulse, delay for another amount of time, andrepeat the pulse generating process. Also, in some embodiments, themicrocontroller could be programmed to cause the pulse generation moduleto deliver a hyperpolarizing pulse before the first spike of each groupof multiple spikes.

FIG. 3 depicts a block diagram of IPG 200 that may be programmed todeliver burst and tonic stimulation in accordance with somerepresentative embodiments. IPG 200 comprises battery 301, pulsegenerating circuitry 302, output switch matrix 303, control circuitry304, and communication circuitry 305. Control circuitry 304 controls thegeneration of pulses by pulse generating circuitry 302 and the deliveryof the generated pulses by output switch matrix 303. Specifically,control circuitry 304 controls the amplitude and pulse width of arespective pulse by controlling pulse generating circuitry 302.Additionally, control circuitry 304 controls the timing of thegeneration of pulses by controlling pulse generating circuitry 302.Control circuitry 304 further configures output switch matrix 303 tocontrol the polarity associated with a plurality of outputs associatedwith switch matrix 303. In one representative embodiment, controlcircuitry 304 is implemented using a microcontroller (or other suitableprocessor) and suitable software instructions stored thereon orotherwise to implement the appropriate system control. Alternatively,control circuitry 304 may comprise an application specific integratedcircuit.

Control circuitry 304 preferably controls pulse generating circuitry 302and output switch matrix 303 using “multi-stim set programs” which areknown in the art. As used herein, a “stim set” refers to a set ofparameters which define a pulse to be generated and how the pulse is tobe delivered. As shown in FIG. 3, a plurality of stim sets 306 aredefined in memory of IPG 200. The memory can be integrated with controlcircuitry 304 or provided separately in IPG 200. Each stim set defines apulse amplitude, a pulse width, (optionally a pulse delay), and anelectrode combination. The pulse amplitude refers to the amplitude for agiven pulse and the pulse width refers to the duration of the pulse. Thepulse delay represents an amount of delay to occur after the generationof the pulse (equivalently, an amount of delay could be defined to occurbefore the generation of a pulse). The amount of delay represents anamount of time when no pulse generation occurs. In lieu of providing adelay parameter, another stimset could be defined to provide a “pulse”with zero pulse amplitude to implement delay between other non-zeroamplitude pulses. The electrode combination defines the polarities foreach output of output switch matrix 303 which, thereby, controls how apulse is applied via electrodes of a stimulation lead. Other pulseparameters could be defined for each stim set such as pulse type,repetition parameters, etc.

As shown in FIG. 3, IPG 200 comprises a plurality of stimulationprograms 307. A stimulation program preferably defines a plurality ofpulses to be generated in succession and the frequency of repetition ofthe pulses. Specifically, when control circuitry 304 executes astimulation program, control circuitry 304 first retrieves thestimulation parameters for the first stimulation set of the stimulationprogram. Control circuitry 304 modifies an amplitude setting of pulsegenerating circuitry 302 according to the amplitude parameter of thestim set. Control circuitry 304 also configures output switch matrix 303according to the electrode combination of the stim set. Then, controlcircuitry 304 causes pulse generating circuitry 302 to generate a pulsefor an amount of time as defined by the pulse width parameter.

Control circuitry 304 stops the pulse generation and waits an amount oftime as defined by a delay parameter (or equivalently by an amount oftime defined by a inter-burst frequency parameter) or by an amount oftime defined by another stim set in which the pulse amplitude is set tozero. Control circuitry 304 then proceeds to the next stimulation set inthe stimulation program and repeats the process. Each stimulation set inthe stimulation program is processed in the same manner. When the laststimulation set of the stimulation program is completed, controlcircuitry 304 waits an amount of time as defined by the frequencyparameter of the stimulation program before beginning again. In anotherimplementation, a delay parameter or zero-amplitude stim set can bedefined for the end of the stimulation program to cause the stim setprogram to function at the desired frequency. That is, the total time ofexecution of one cycle through the stim sets of the program equals thereciprocal of the desired stimulation program frequency. Controlcircuitry 304 repeats the entire process by generating another series ofpulses according to the various stim sets. Thereby, a pulse is generatedfor each stim set according to the defined frequency of the stimulationprogram.

In certain embodiments for chronic pain and other neurologicaldisorders, the stimulation parameters may comprise a burst stimulationat 6, 18, or 40 Hz consisting of 5 spikes with 1 ms pulse width, 1 msinterspike interval in combination with a 6, 18, or 40 Hz tonicstimulation interspersed between or around the bursts.

FIGS. 4 and 5 depict how stim sets and a stimulation program can bedefined to generate burst and tonic stimulation according to onerepresentative embodiment. FIG. 5 depicts a plurality of pulses 501-507.Pulses 501-505 are pulses of a discrete stimulation burst. The amplitudeof pulses 501-505 can be defined in the amplitude parameters (shown asPA₁ through PA₅) of a plurality of stim sets. Each pulse lasts for anamount of time which is defined by the pulse width parameters of theplurality of stim sets (shown as PW₁ through PW₅). The pulses are outputaccording the polarities of the electrode combinations (shown as EC₁through EC₅) of the stim sets. Preferably, each electrode combination ofthe burst stimulus is the same. The inter-pulse or inter-spike intervalsare defined by the delay parameters (shown as PD₁ through PD₄) of thestim sets.

A relatively small amount of delay can be defined to occur after thelast pulse 505 of the burst stimulus before a charge balancing pulse 506occurs. The electrode combination (shown as EC₆) of the chargingbalancing pulse 506 is preferably the opposite of the electrodecombination used for each pulse of the burst stimulus. That is, for eachanode of the burst stimulus, the charging balancing pulse 506 willconfigure those outputs as cathodes (and vice versa). Another delayoccurs after the charging balancing pulses 506 as defined by the delayparameter (shown as PD₆) for the respective stim set.

The last pulse 507 is a stimulation pulse for the tonic stimulation. Theamplitude of the tonic stimulation pulse is defined by the amplitudeparameter (shown as PA₇) of the respective stim set. The duration of thetonic stimulation pulse 507 is defined by the pulse width parameter(shown as PW₇) of the respective stim set. The tonic stimulation pulseis output according to the electrode combination of the respective stimset (shown as EC₇). The electrode combination of the tonic stimulationmay be the same as the electrode combination for the burst stimulationor may differ from the electrode combination for the burst stimulation.The delay parameter for the last stim set is not shown. Any suitablevalue could be assigned to the last stim set as long as the delay valuepermits a stimulation program to be repeated at an appropriatefrequency.

FIG. 4 depicts stimulation program 400 for the stimulation pattern shownin FIG. 5. Stimulation program 400 identifies stim sets SS1-SS7 asbelonging to the stimulation program. Accordingly, when stimulationprogram 400 is executed by IPG 200, stimulation pulses will besuccessively generated according to the parameters of the stim sets.Stimulation program 400 defines the frequency for the stimulationprogram, in this case, 40 Hz (although any suitable frequency could beselected). The burst stimulation and the tonic stimulation as defined bythese stim sets will be repeated according to the defined frequencyparameter.

Referring again to FIG. 3, the parameters associated with the variousstim sets and stimulation programs are preferably communicated to IPG200 using communication circuitry 305. For example, an externalprogramming device may communicate the various parameters of the stimsets to IPG 200. Then, the external programming device may communicateparameters defining a given stimulation program according to the createdstim sets. It shall be appreciated that the parameters shown in FIGS.2-5 are by way of example only. Other parameters may be utilized todefine burst and/or tonic stimulation. For example, burst parameterscould be communicated from the programming device to IPG 200 (e.g.,burst amplitude, inter-pulse or inter-spike interval, intra-burst spikerepetition rate, pulse number, etc.), and IPG 200 could automaticallyconfigure parameters in its internal memory or registers in responsethereto.

FIG. 6 depicts stimulation pattern 600 that includes a combination ofburst stimulation and tonic stimulation that can be used to treat aneurological condition or disorder according to one representativeembodiment. The individual pulses of stimulation pattern 600 could bemanually defined by defining the pulse width, amplitude, delayparameters for respective stim sets and assembling the stim sets into astimulation program. A manual process of defining stim sets in thismanner can be time consuming during trial stimulation when an optimalstimulation pattern is sought for a patient's specific neurologicalcondition or disorder. Accordingly, some embodiments provide auser-interface that is adapted to permit the creation of burst and tonicstimulation patterns in an efficient manner.

FIG. 7 depicts user interface 700 that can be employed to define burstand tonic stimulation according to one representative embodiment. Userinterface 700 can be implemented using suitable executable code storedon controller 250. Alternatively, the executable code could be residenton a separate system (e.g., a laptop computer) that uses controller 250to communicate control signals to IPG 210.

User interface 700 comprises a first plurality of controls 710 and asecond plurality 720 of controls. The first plurality 710 of controlsallows selection of multiple stimulation parameters for a plurality ofstimulation sets 711-1 through 711-8. For example, pulse amplitude andpulse width parameters can be controlled for each stimulation set 711.Conventional pulse calibration parameters, such a perception thresholdvalue and a max tolerable limit, are preferably controllable for thestimulation sets 711 in the first plurality 710 of controls. Eachstimulation set 711 is associated with a frequency parameter whichdefines an amount of time until the next stimulation set is selected.Alternatively, the frequency parameter could be equivalently representedby a time-interval delay value.

The second plurality 720 of controls allowing selection of multiplestimulation parameters defining a burst stimulation pattern and a tonicstimulation pattern to be interleaved for delivery to the patient. Forexample, the number of spikes in an individual burst of the stimulationpattern is controlled by control 721. The amplitude and pulse width ofthe individual burst pulses are controlled by controls 722 and 723,respectively. In one embodiment, pulse ramping may be automaticallyimplemented. Specifically, pulse amplitudes may be automatically scaledfrom a beginning value to a maximum value in relation to the value inputby the user into control 723. The amplitude and pulse width of the tonicstimulation to be interspersed between burst stimulation are controlledby controls 725 and 726, respectively. Control 727 allows the amount oftime between the end of an individual burst and the occurrence of atonic pulse to be controlled. The amount of time could be automaticallycalculated. For example, the midpoint between the end of the burst andthe beginning of another burst could be selected for the tonic pulse andautomatically calculated by software code in response to changes inother stimulation parameters. Control 724 controls the overall frequencyof the combination of burst stimulation and tonic stimulation.

When a clinician provides input to change one or more parameter valuesin the second plurality 720 of controls, the user interface codepreferably automatically recalculates and adjusts the parameter valuesfor the respective stim sets 711-1 through 711-8 in the first plurality710 of controls. For example, if the clinician modifies the number ofpulses in an individual burst via control 721, the code automaticallymodifies the appropriate ones of stim sets 711-1 through 711-8 toreflect the pulse amplitude, pulse width, and an suitable pulsefrequency. Also, the code automatically modifies frequency parameters(or equivalently delay parameters) associated with the other stim setsin view of the modification of the number of burst pulses so that thestimulation program is consistent with the overall stimulation frequencyshown in control 724.

The clinician is thereby able to efficiently define a stimulationprogram including a combination of burst stimulation and tonicstimulation for a particular patient for the patient's particularneurological disorder or condition. If desired, the clinician canattempt to optimize the stimulation program by modifying the specificparameters of the stim sets 711 on an individual basis. The cliniciancould attempt to modify the amplitude and/or pulse width of individualpulses of the burst stimulation. Similarly, the clinician could modifythe timing between individual pulses of the burst stimulation. Thus, theclinician is able to finely tune the stimulation program, if desired,while not being required to manually select each and every stimulationparameter of the stimulation program.

In some embodiments, when the clinician wishes to test or finalize thestimulation program, the clinician may select control 728. In response,the code associated with interface 700 communicates the stimulation setparameter values to the respective IPG. The IPG can then execute thestimulation program defined by the stimulation sets. The clinician mayelicit feedback from the patient to determine whether the desired effectof the stimulation has been achieved (e.g., suppression of tinnitus,relief from the patient's chronic pain, etc.). Alternatively, variousmechanisms may be utilized to determine whether the stimulation programis deemed effective without requiring the patient's conscious response(e.g., by measuring the evoked release of neurotransmitters for corticalor deep brain stimulation) depending upon the particular neurologicalcondition or disorder being treated.

Any suitable neuronal site can be stimulated using combination of burststimulation and tonic stimulation according to some representativeembodiments. Suitable sites can include, for example, peripheralneuronal tissue and/or central neuronal tissue. Peripheral neuronaltissue can include a nerve root or root ganglion or any neuronal tissuethat lies outside the brain, brainstem or spinal cord. Peripheral nervescan include, but are not limited to olfactory nerve, optic, nerve,oculomotor nerve, trochlear nerve, trigeminal nerve, abducens nerve,facial nerve, vestibulocochlear (auditory) nerve, glossopharyngealnerve, vagal nerve, accessory nerve, hypoglossal nerve, suboccipitalnerve, the greater occipital nerve, the lesser occipital nerve, thegreater auricular nerve, the lesser auricular nerve, the phrenic nerve,brachial plexus, radial axillary nerves, musculocutaneous nerves, radialnerves, ulnar nerves, median nerves, intercostal nerves, lumbosacralplexus, sciatic nerves, common peroneal nerve, tibial nerves, suralnerves, femoral nerves, gluteal nerves, thoracic spinal nerves,obturator nerves, digital nerves, pudendal nerves, plantar nerves,saphenous nerves, ilioinguinal nerves, gentofemoral nerves, andiliohypogastric nerves.

Central neuronal tissue includes brain tissue, spinal tissue orbrainstem tissue. Brain tissue can include thalamus/sub-thalamus, basalganglia, hippocampus, amygdala, hypothalamus, mammilary bodies,substantia nigra or cortex or white matter tracts afferent to orefferent from the abovementioned brain tissue, inclusive of the corpuscallosum, more particularly, the brain tissue includes the auditorycortex and/or somatosensory cortex. Brainstem tissue can include themedulla oblongata, pons or mesencephalon, more particular the posteriorpons or posterior mesencephalon, Lushka's foramen, and ventrolateralpart of the medulla oblongata.

Spinal tissue can include the ascending and descending tracts of thespinal cord, more specifically, the ascending tracts of that compriseintralaminar neurons or the dorsal column. For example, the spinaltissue can include neuronal tissue associated with any of the cervicalvertebral segments (C1, C2, C3, C4, C5, C6, C7 and C8) and/or any tissueassociated with any of the thoracic vertebral segments (T1, T2, T3, T4,T5, T6, T7, T8, T9, T10, T11, 12) and/or any tissue associated with anyof the lumbar vertebral segments (L1, L2, L3, L4. L5, L6) and/or anytissue associated with the sacral vertebral segments (S1, S2, S3, S4,S5).

Although certain representative embodiments and advantages have beendescribed in detail, it should be understood that various changes,substitutions and alterations can be made herein without departing fromthe spirit and scope of the appended claims. Moreover, the scope of thepresent application is not intended to be limited to the particularembodiments of the process, machine, manufacture, composition of matter,means, methods and steps described in the specification. As one ofordinary skill in the art will readily appreciate when reading thepresent application, other processes, machines, manufacture,compositions of matter, means, methods, or steps, presently existing orlater to be developed that perform substantially the same function orachieve substantially the same result as the described embodiments maybe utilized. Accordingly, the appended claims are intended to includewithin their scope such processes, machines, manufacture, compositionsof matter, means, methods, or steps.

What is claimed is:
 1. A method for defining a stimulation program forelectrical stimulation of a patient to treat chronic pain of a patient,the method comprising: providing a single screen user interface thatcomprises a first plurality of controls and a second plurality ofcontrols, the first plurality of controls allowing selection of multiplestimulation parameters for application to multiple stimulation pulses ofa complex pulse pattern, wherein (i) the first plurality of controlscomprises controls for defining a burst subset of pulses within thecomplex pulse pattern and at least one tonic pulse within the complexpulse pattern and (ii) each control of the second plurality of controlsallows selection of at least one stimulation parameter of one respectivepulse within the complex pulse pattern, wherein (A) the complex pulsepattern produces a repeating pattern of multiple pulses at a fixed pulserate followed in sequence by a first delay, a tonic pulse, and a seconddelay before repeating, and (B) the first delay and the second delay areconstant in the repeating pattern; receiving user input in one or moreof the first plurality of controls; automatically modifying parametersfor respective pulses in the complex pulse pattern in response toreceiving the user input in one or more of the first plurality ofcontrols and automatically modifying values displayed in one or morecontrols of the second plurality of controls according to the modifiedparameters, wherein the automatically modifying values displayed in oneor more controls of the second plurality of controls comprisesautomatically adjusting at least one of the first delay and the seconddelay in the complex pattern according to an overall pattern frequencyrate defined using the first plurality of controls; creating astimulation program employing the complex pulse pattern for electricalstimulation of the patient for storage in an implantable pulsegenerator; and operating the implantable pulse generator to deliverstimulation with the complex pulse pattern to the patient using spinalcord stimulation to treat chronic pain of the patient.
 2. The method ofclaim 1 wherein the automatically modifying comprises: calculating aplurality of amplitudes for multiple pulses of the burst subset ofpulses to define pulse ramping in response to selection of a singleamplitude value for the burst stimulation in the first plurality ofcontrols.
 3. The method of claim 1 wherein the modified parameters arestored in a plurality of stimulation sets and the automaticallymodifying parameters for respective pulses comprises: modifying aplurality of parameter values for respective stimulation sets inresponse to selection of a number of pulses for the burst stimulation inthe first plurality of controls.
 4. The method of claim 1 wherein theplurality of first controls comprises a control for controlling a pulsewidth of pulses of the burst stimulation.
 5. The method of claim 1wherein the first plurality of controls comprises a control forcontrolling an amplitude of the tonic stimulation.
 6. The method ofclaim 1 further comprising: generating a waveform display of thestimulation program.
 7. The method of claim 1 wherein the modifiedparameters are stored in a plurality of stimulation sets and the methodfurther comprising: communicating parameter values for stimulation setsof the stimulation program to an implantable pulse generator forexecution of the stimulation program by the implantable pulse generator.